Assessing clinical research coordinator knowledge of good clinical practice: An evaluation of the state of the art and a test validation study.

James M Dubois,Kari Baldwin,Michelle Jenkerson,Alison L Antes,Jessica T Mozersky

doi:10.1017/cts.2019.440

James M Dubois, Kari Baldwin + Show 3 more

Open Access

https://doi.org/10.1017/cts.2019.440

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Abstract

This paper describes the development and validation of a new 32-item test of knowledge of good clinical practice (GCP) administered to 625 clinical research coordinators. GCP training is mandated by study sponsors including the US National Institutes of Health. The effectiveness of training is rarely assessed, and the lack of validated tests is an obstacle to assessment. The GCP knowledge test was developed following evaluation of two existing widely used GCP tests to ensure it accurately reflects the content of current training. The final GCP knowledge test demonstrated good reliability (α = 0.69). It is a valid and reliable instrument for measuring knowledge of GCP. The test will be useful in assessing the effectiveness of GCP training programs as well as individuals' mastery of GCP content.

Highlights

International standards for good clinical practice (GCP) foster participant safety, regulatory compliance, and scientific rigor [1,2]
The 136 existing items that we evaluated prior to writing original items addressed five of eight core areas of GCP: clinical trial operations (n = 66); study and site management (n = 27); ethical and participant safety considerations (n = 21); medicines development and regulation (n = 10); and data management and informatics (n = 7)
It is a strength that the test reflects the current content of courses as this enables it to be used to assess clinical research coordinators (CRCs)’ mastery of training material

Summary

Introduction

International standards for good clinical practice (GCP) foster participant safety, regulatory compliance, and scientific rigor [1,2]. The importance of clear standards for GCP has increased as clinical trials have grown increasingly complex and international in scope. GCP training is a key component of ensuring that clinical trialists are prepared to meet their professional obligations. A growing number of professional societies, funding agencies, and clinical trial sponsors offer GCP training programs [4]. GCP training programs are currently highly variable in format (including diverse online and face-to-face formats), duration (from 45 minutes to lengthy certification programs), and scope of content. It is unclear how well curricula cover the proposed eight competencies [5,6]

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